Curriculum Vitae, Corinna Alisangco Gamez, M.D. Corinna Alisangco Gamez, M.D. Pacific Research Partners, LLC. 901 Clay Street Oakland, CA 94607

Transcription

1 CONTACT INFORMATION: Site Selection and Information: Bobbie Theodore, Alliance Director Tel. (916) Fax (208) AFFILIATIONS: Collaborative Neuroscience Network, LLC Valley View Street, Suite 3 Garden Grove, CA Collaborative Neuroscience Network, LLC 2600 Redondo Avenue, Suites 415 & 500 Long Beach, CA Collaborative Neuroscience Network, LLC S. Vermont Avenue, Suite F-100 Torrance, CA EDUCATION: Corinna Alisangco Gamez, M.D. Pacific Research Partners, LLC. 901 Clay Street Oakland, CA M.D., University of Santo Tomas, Manila, Philippines 1987 B.S., University of Santo Tomas, Manila, Philippines INTERNSHIPS and RESIDENCIES: Fellow in Substance Abuse, San Francisco VAMC/UCSF, San Francisco, CA Fellow in Consultation-Liaison Psychiatry, Harvard Longwood Program, Brigham and Women s Hospital, Boston, MA/West Roxbury VAMC Chief Resident and Fellow - Psychiatry in Primary Care (PRIME Fellow) Harvard, South Shore Program, West Roxbury VAMC, W. Roxbury, MA PGY-III Psychiatry, Harvard Medical School - South Shore Program Brockton/W. Roxbury VAMC, Brockton, MA Updated 12/21/2018 1

2 INTERNSHIPS and RESIDENCIES (continued): PGY-II Psychiatry, Harvard Medical School - South Shore Program Brockton/W. Roxbury VAMC, Brockton, MA PGY-I Psychiatry Internship, Harvard Medical School - South Shore Program, Brockton/W. Roxbury VAMC Externship in Internal Medicine, Santo Tomas University Hospital Manila, Philippines Rotating Internship, Santo Tomas University Hospital, Manila, Philippines LICENSURE and CERTIFICATION: Re-certified in General Psychiatry and Subspecialty in Addiction Psychiatry, American Board of Psychiatry & Neurology, 2013 Certified in Subspecialty in Addiction Psychiatry, American Board of Psychiatry & Neurology, 2004 Diplomate, American Board of Psychiatry & Neurology, 2002 California State Medical License, 1999 Massachusetts State Medical License, 1996 PROFESSIONAL EXPERIENCE: Investigator, October present Pacific Research Partners, LLC, Oakland, CA Sub-Investigator, August present Pacific Research Partners, LLC, Oakland, CA Medical Director, 2003 Present OBIC - Outpatient Buprenorphine Induction Clinic, UCSF/SFGH San Francisco, CA Associate Clinical Professor, 2002 Present UCSF, Department of Psychiatry, Division of Substance Abuse and Addiction Medicine San Francisco General Hospital San Francisco, CA Medical Director, 2007 May North McAuley Institute, Adolescent Day Treatment, St. Mary s Medical Center San Francisco, CA Attending Psychiatrist, 2004 August North McAuley Institute, In-patient Psychiatric Unit, St. Mary s Medical Center San Francisco, CA Updated 12/21/2018 2

3 PROFESSIONAL EXPERIENCE (continued): Consultant Psychiatrist, Asian Pacific Islander Wellness Center (API HIV Focus Treatment) San Francisco, CA Medical Director, Asian-American Recovery Services San Francisco, CA INVESTIGATOR EXPERIENCE: Phase I Addiction Binge Eating Disorder Bipolar Disorder Depression Diabetes Fibromyalgia Healthy Migraine Obsessive Compulsive Disorder Opioid Use Disorder Schizophrenia and Schizoaffective Disorder Sexual Dysfunction Smoking Cessation Tardive Dyskinesia CLINICAL TRIAL EXPERIENCE: Phase I A Phase Ib, Pivotal, Multiple-Dose, Pharmacokinetic Bioequivalence Trial Comparing Generic to Reference XXX Extended-Release Injectable Suspension (156 mg/1.0 ml) in Patients with Schizophrenia or Schizoaffective Disorder A Phase I, Randomized, Crossover, Open-Label, Multiple Dose, Pivotal Pharmacokinetic Bioequivalence Study Comparing XXX Extended-Release IM 156 mg/1 ml (100 mg eq) with XXX in Subjects with Schizophrenia or Schizoaffective Disorder A Phase I, XXX Sub-study 002: Study of XXX and Android App Performance and Usability. A Phase I, RW2 Confirmatory Study of the XXX system. The system is designed to enable mental health patients to measure and monitor their medication adherence as well as other information such as mood, rest, and activity. A Phase I Randomized, Open-Label, Parallel Design, Multiple-Dose, Comparative Bioequivalence Study of XXX Extended-Release Injectable Suspension (156 mg/1.0 ml) Versus XXX Extended-Release Injectable Suspension (156 mg/1.0 ml) in Schizophrenia Patients Already Stabilized on XXX A Phase I, Randomized, Open-label, Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of XXX Following Administration to the Deltoid or Gluteal Muscle in Adults with Schizophrenia or Schizoaffective Disorder A Phase I Study of XXX and XXX Co-administered with XXX in Adults with Schizophrenia Updated 12/21/2018 3

4 A Phase I, Reliability and validity of an online neurocognitive test battery, the XXX Test, in normal healthy adults Addiction A Phase III, Open-Label, Depot XXX Treatment Extension Study in Subjects With Opioid Use Disorder A Phase III, Open-Label, Long-Term Safety and Tolerability Study of XXX in Treatment- Seeking Subjects With Opioid Use Disorder A Twelve Week, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Ranging Study with Follow Up Evaluating the Safety and Efficacy of XXX for Smoking Cessation in Healthy Adolescent Smokers A Phase III, Multicenter, Open-label, 12-month Extension Safety and Tolerability Study of XXX in the Treatment of Adults with Binge Eating Disorder Bipolar Disorder A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of XXX in the Treatment of Subjects with Bipolar I Disorder A Multicenter, Randomized, Double-blind Trial of XXX versus Placebo for the Acute Treatment of Subjects Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder A Phase III, andomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of XXX in the Treatment of Patients with Major Depressive Episodes Associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) A Phase III, Randomized, Double-Blind,Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of XXX Monotherapy in the Treatment of Patients with Major Depressive Episodes Associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Fixeddose Clinical Trial Evaluating the Efficacy, Safety and Tolerability of XXX in Patients with Bipolar I Depression A Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Once a Day, XXX for Sublingual Administrations (XXX Tablet) 0.1mg and 0.4mg as an Adjunctive Therapy in the Treatment of Acute Depressive Episodes Associated with Bipolar I Disorders in Adult Subjects Updated 12/21/2018 4

5 Depression A Double-Blind, Placebo-Controlled, Phase II Trial to Test Efficacy and Safety of XXX as Adjunct to Current Antidepressant Therapy in Patients with Major Depressive Disorder (MDD) with an Inadequate Response to Current Antidepressants A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of XXX as Adjunctive Therapy in the Maintenance Treatment of Adults With Major Depressive Disorder A Double-Blind, Placebo-Controlled, Fixed-Dose Study of XXX in Patients with Major Depressive Disorder A Study of XXX Plus XXX in Treatment-Resistant Depression (TRD) A Phase II/III, Randomized, Double-blind, Active-controlled Trial to Assess the Efficacy and Safety of XXX Administered Orally to Subjects with Treatment Resistant Major Depressive Disorder A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive XXX in Major Depressive Disorder An Open-Label, Single-Arm, Multicenter, Prospective, Phase IV, Interventional, Flexible Dose Study to Evaluate the Effectiveness of XXX on Goal Achievement After a Change in Antidepressant Medication for the Treatment of Subjects With Major Depressive Disorder - Goal Achievement After a Change to XXX in Adults With Major Depressive Disorder An Phase III, Open-label, Long-term Safety Study of XXX as Adjunctive Therapy in Patients with Major Depressive Disorder A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of XXX as Adjunctive Therapy in the Prevention of Relapse in Patients with Major Depressive Disorder A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of XXX as Adjunctive Therapy in Major Depressive Disorder A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Intermittent Doses of XXX in the Treatment of Subjects with Severe Depression despite Antidepressant Treatment A Phase III, Open-label Long-term Extension Safety Study of Intranasal XXX in Treatmentresistant Depression Updated 12/21/2018 5

6 A Phase III, 8-Week Prospective Randomized, Controlled, Single-Blind Trial of the XXX vs. Treatment-as-Usual to Evaluate Efficacy of Assay-Guided Treatment in Adults with Major Depressive Disorder A Phase III, Non-Interventional Study of Subjects who have participated in XXX, A Study of Adjunctive Treatment of Major Depressive Disorder A Phase II, Multicenter Double-Blind Placebo-Controlled Dose Finding Study of XXX in Patients with Major Depressive Disorder (MDD) A Phase III, Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal XXX Plus an Oral Antidepressant in Adult Subjects with Treatment-resistant Depression A Phase II, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of XXX as an adjunctive therapy in patients with major depressive disorder with an inadequate response to antidepressant treatment A Phase III Efficacy and Safety Study of XXX for the Adjunctive Treatment of Major Depressive Disorder A Phase III Multicenter Study of the Long-term Safety and Tolerability of XXX for the Adjunctive Treatment of Major Depressive Disorder in Adults who Have an Inadequate Response to Antidepressant Therapy A Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Study of XXX in the Adjunctive Treatment of Subjects with Severe Depression and Recent Active Suicidal Ideation Despite Antidepressant Treatment A Double-Blind, Placebo-Controlled, Randomized Add-On Study of XXX For Patients With Major Depressive Disorder (MDD) Who Have Had An Inadequate Response to Current Antidepressant Therapy Fibromyalgia An Phase III Open-label Extension Study of XXX for 52 weeks in Pain Associated with Fibromyalgia A Phase III,randomized, double-blind, double-dummy, placebo- and active-controlled, multi-center study of XXX in subjects with pain associated with fibromyalgia Updated 12/21/2018 6

7 Migraine A Phase III, Multicenter, Randomized, Open-label Study to Evaluate the Longterm Safety and Tolerability of Oral XXX for the Prevention of Migraine in Patients with Episodic Migraine A Phase III, Randomized, Double blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of XXX in Migraine Prevention A Multicenter, Open Label, Long-Term Safety Study of XXX in Patients with Acute Migraines A Phase III, Double-Blind, Randomized, Placebo Controlled, Safety, Efficacy, Trial of XXX for the Acute Treatment of Migraine A Phase III, Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy, Tolerability, and Safety Study of XXX in Episodic Migraine With or Without Aura A Phase III, Open-label, Long-term, Safety Study of XXX (100 mg and 200 mg) in the Acute Treatment Of Migraine A Phase III, Study of Three Doses of XXX (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine: A Randomized, Double-blind, Placebo-controlled Parallel Group Study A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of LY in Patients with Episodic Migraine the XXX 2 Study A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Phase II Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of XXX Administered Intravenously in Patients with Chronic Migraine Post-Traumatic Stress Disorder A 40-Week Open-Label Extension Study to Evaluate XXX SL Taken Daily at Bedtime in Patients with PTSD A Phase III, 12-Week Open-Label Extension Study to Evaluate XXX Taken Daily at Bedtime in Patients with PTSD A Phase III, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XXX Taken Daily at Bedtime in Patients with Military-Related PTSD Updated 12/21/2018 7

8 Schizophrenia A Phase II Randomized, Sham-Controlled Study of XXX as an adjunct to standard-of-care treatment for schizophrenia Tocreate opportunities for the XXX Sponsor to interface with people with schizophrenia and to obtain their feedback on XXX prototypes A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-group Study to Assess the Safety and Efficacy of XXX as Add-on Treatment for Cognitive Impairment in Subjects with Schizophrenia on Stable Doses of Antipsychotic Medication A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Risperidone Extended-Release Injectable Suspension XXX for Subcutaneous Use as Maintenance Treatment in Adult Patients with Schizophrenia A Double-blind, Randomized, Active-controlled, Parallel-group Study of XXX 6-Month Formulation A Phase III, Study to Assess the Long-Term Safety, Tolerability, and Durability of Treatment Effect of XXX in Subjects with Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder A Phase IIb/III, Adaptive, Multi-center, Prospective, Randomized, Double-blind, Placebocontrolled Study of the Safety and Efficacy of XXX, a D-Amino Acid Oxidase Inhibitor, as an Add-on Treatment for Schizophrenia in Adults Pilot study for Validation Test Plan XXX study A Phase III, Open-Label, Multi-Center Trial to Assess the Safety and Effectiveness of XXX in Patients with Schizophrenia A Phase IIb, Multicenter, Randomized, Double-blind, Parallel group, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of XXX as Adjunctive Treatment in Patients with Cognitive Impairment Associated with Schizophrenia Treated with Antipsychotics A Phase III, 52-Week, Open-Label, Extension Study of XXX for the Adjunctive Treatment of Schizophrenia A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XXX as Adjunctive Treatment for the Negative Symptoms of Schizophrenia A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Adjunctive XXX for the Treatment of Schizophrenia Updated 12/21/2018 8

9 A Fifteen-Month, Prospective, Randomized, Active-Controlled, Open-Label Flexible-Dose Study of XXX Compared with Oral Antipsychotic Treatment in Delaying Time to Treatment Failure in Adults with Schizophrenia who Have Been Incarcerated A Phase III Study to Evaluate Weight Gain of XXX Compared to XXX in Adults with Schizophrenia A Phase III, One Year, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of XXX as a Maintenance Treatment in Patients with Schizophrenia XXX for Cannabis Use Disorder in Schizophrenia A Phase II, multicenter, randomized, double blind, placebo-controlled study to assess the efficacy, safety and tolerability of XXX for the treatment of negative symptoms of schizophrenia An Phase III, Open-Label, Long-Term Safety and Tolerability Study of XXX in the Treatment of Subjects With Schizophrenia A Phase III, Multicenter, Extension of Study XXX to Assess the Long-term Safety and Durability of Effect of XXX in Subjects with Stable Schizophrenia A Phase II, Randomized, Multicenter, Safety, Tolerability, and Dose-Ranging Study of XXX, a Component of XXX, in Adults with Schizophrenia Treated with XXX A Randomized, Double-blind, Placebo-controlled, Parallel, 26-Week, Phase III Study of 2 Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (XXX) or Placebo as an Adjunctive Pro-cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy A Multicenter 26-Week Extension Study to Evaluate the Safety and Clinical Effects of Prolonged Exposure to 1 and 2 mg Doses of XXX, an Alpha-7 Nicotinic Acetylcholine Receptor Agonist, as an Adjunctive Pro-cognitive Treatment in Subjects with Schizophrenia on Chronic Stable Atypical Antipsychotic Treatment A Twelve Week, Randomized, Phase II, Double-blind, Parallel-Group Study of two Dose Levels of XXX Compared to Placebo in the Adjunctive Treatment Of Outpatients with Sub-Optimally controlled Sympotoms of Schizophrenia A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of XXX (90 mg and 120 mg) as a Treatment in Subjects with Acute Schizophrenia Over 8 Weeks Updated 12/21/2018 9

10 Tardive Dyskinesia A Phase III, Open-Label Rollover Study for Continuing XXX Administration for the Treatment of Tardive Dyskinesia A Phase III, Open-Label, Safety and Tolerability Study of XXX for the Treatment of Tardive Dyskinesia A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel, Fixed-dose Study to Assess the Efficacy, Safety, and Tolerability of XXX for the Treatment of Tardive Dyskinesia A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy, Safety, And Pharmacokinetic Behavior of Orally Administered XXX in Subjects with Drug Induced Tardive Dyskinesia Other Indications A Phase III, Randomized, Multicenter, Open-Label, Parallel-Group Clinical Study Comparing the Safety and Efficacy of XXX in Type 1 Diabetes Mellitus Patients A Phase II/III Randomized, Double-blind, Placebo-controlled trial of XXX in Subjects with Obsessive Compulsive Disorder A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Subcutaneously Administered XXX in Premenopausal Women with Hypoactive Sexual Desire Disorder (HSDD) (with or without Decreased Arousal) COMMITTEE ASSIGNMENTS: Chairman, Medical Substance Abuse Committee San Francisco General Hospital 2003 Group Leader, Buprenorphine Training Office Based Treatment of Opiate Addiction Training Committee Member, Brockton/W. Roxbury VAMC 1991 Secretary, Faculty of Medicine and Surgery University of Santo Tomas, Manila, Philippines Updated 12/21/

11 FUNDED RESEARCH: NIH/NIDA Lead Physician, UCSF West Coast Node, California-Arizona Clinical Trials Network (CTN). POATS Prescription Opiate Addiction Treatment Study. National Study on Treatment of prescription addicted patients using Buprenorphine. The University of CA, San Francisco participated in the NIDA sponsored CTN cooperative agreement. TEACHING EXPERIENCE: 2001 Present Ongoing Teaching of UCSF Medical Residents, Attendings, and Nurse Practitioners Rotating at UCSF Substance Abuse program and DPH/IBIS Buprenorphine Induction Clinic Clinical Supervisor, Pre-doctoral Intern, Clinical Psychology UCSF Dept. of Psychiatry 2003 UCSF Surgery Interns & Residents, Management of Alcohol and Opiate Withdrawal Symptoms Among Surgical Inpatients UCSF Psychiatry Interns & Residents, Introduction to Substance Abuse and Addiction Medicine Teaching and Supervision of CPMC (California Pacific Medical Center) Psychiatry Residents Rotation to Opioid Treatment Outpatient Program 1999 Instructor, Introductory to Clinical Medicine (ICM) Harvard Medical School/ MIT Health Science Training MD/PhD Program 1998 Psychiatry Resident Supervisor at Harvard Medical School, Longwood Program 1997 Psychiatry Resident Supervisor at Harvard Medical School, South Shore Program PUBLICATIONS: Pletcher MJ, Fernandez A, May TA, Westphal JR, Gamez CA, Hersh DF, Gonzales R. Unintended consequences of a quality improvement program designed to improved treatment of alcohol withdrawal in hospitalized patients. Jt Comm J Qual Saf 2005; 31(3): Chemali Z, Gamez C, Fricchione G. A Neonatal Case Report. Altered Mental Status in a Newborn of a Mother with Psychiatric Health Problems: The Role of Psychiatric Consultation. Birth Issues 2004;13(2): Updated 12/21/

12 PRESENTATIONS: "A Dosing Review of Lorazepam Infusions in the Treatment of Severe Alcohol Withdrawal in a Transition Care Unit". Poster Presentation for the 12 th Annual Meeting & Symposium, American Academy of Addictions Psychiatry, Amelia Island, FL, December "Disorders of the Thinking Process", Advanced Psychopathology Course Seminar, West Roxbury VAMC, Psychiatry Grand Rounds Chair, Case Presentation, Brockton/W. Roxbury VAMC, "Use of Oral Rehydration Solutions in the Third World". Annual Interns' Paper Presentation, Santo Tomas University Hospital, "Increasing the Yield of Tuberculosis Bacilli in the Sputum". Presented at the Second Annual Medical Seniors' Scientific Paper Presentation, University of Santo Tomas, Updated 12/21/